Made by AbbVie of North Chicago, Humira is the brand name for adalimumab, a drug that hit the market in 2002 for treating rheumatoid arthritis. Now, it is used to treat a wide variety of inflammatory conditions associated with a protein that circulates in the bloodstream, called TNF-alpha. Excess amounts of this protein have been observed in the joints of arthritis patients and the gastrointestinal tract of Crohn's patients (for example). By blocking the TNF-alpha protein, Humira treats these conditions by reducing inflammation associate with TNF-alpha.
Humira is a common biologic treatment for Inflammatory Bowel Disease (IBD). When used in Crohn’s disease treatment, Humira is often recommended only for patients who experience moderate to severe symptoms of Crohn’s.
Whether you are currently taking Humira for IBD or simply researching Crohn’s treatments, understanding the worldwide impact of this drug provides important insight into how IBD is treated and what the life cycle for developing new IBD treatments looks like. Learn the facts about Humira below:
It is one of the most comprehensively studied biologics available
Supported by more than 14 years of clinical trials in IBD (Crohn’s disease and ulcerative colitis), Humira is one of the most comprehensively studied treatments for autoimmune disease.
In the U.S., Humira is approved for treating 10 conditions
Humira is used to treat these conditions—and it is still being studied for additional applications:
Rheumatoid arthritis (RA) in adults.
Polyarticular juvenile idiopathic arthritis (JIA).
Ankylosing spondylitis (AS) in adults.
Crohn's disease (CD), to achieve and maintain clinical remission in adults who have not responded well to certain other medications.
Crohn's disease (CD), to achieve and maintain clinical remission in children 6 years of age and older when other treatments have not worked.
Hidradenitis suppurativa (HS) in adults.
Ulcerative colitis (UC) in adults, to induce and sustain remission when other medicines have not worked.
Chronic plaque psoriasis (Ps) in adults.
Non-infectious intermediate, posterior, and panuveitis (UV) in adults.
Humira won an “orphan drug” designation from the FDA
In 2015, Humira won an important designation from the FDA. “Orphan drug” status is given to drugs that treat rare diseases, and the status gave Humira seven years of market exclusivity for treatment of its latest application, hidradenitis suppurativa. This is significant because Humira’s patent expired in 2016, losing its exclusivity for other uses (such as Crohn’s disease), opening up the market to competitors. Humira’s patent expiration has also spurred AbbVie and its competitors to develop new alternatives to the drug, many of which are being developed as biosimilars.
Humira’s parent company has two more IBD drugs in the pipeline
AbbVie has two more IBD drugs currently in Phase 2 trials:
Risankizumab, an investigational IL-23 inhibitor for patients with moderate to severe Crohn's disease.
Upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor for patients who had failed treatments from two or more biologics. This drug is given orally.
It’s expensive to use - and it generates big $$$
Humira is the world’s top-selling pharmaceutical product. It has long been a main revenue stream for AbbVie, accounting for about two-thirds of the company's total sales. It’s estimated that sale of Humira generates about $14 billion per year, with treatment for an individual in the ballpark of $4,000/month.
Often times clinical trial patients receive their medication free of cost and their travel expenses reimbursed. If you are interested in participating in an AbbVie trial, learn more at discovertherapies.com
AbbVie. (2017 May). AbbVie Demonstrates Leadership in Gastroenterology and Hepatology with New Data and Late-Breaking Studies to be Presented at Digestive Disease Week. Retrieved from https://news.abbvie.com/news/abbvie-demonstrates-leadership-in-gastroenterology-and-hepatology-with-new-data-and-late-breaking-studies-to-be-presented-at-digestive-disease-week.htm
Russell, John. (2015 September). Humira: One drug. Nine uses. More on the way? Chicago Tribune. Retrieved from http://www.chicagotribune.com/business/ct-humira-swiss-army-knife-0920-biz-20150918-story.html
(2018). Adalimumab. Wikipedia. Retrieved from https://en.wikipedia.org/wiki/Adalimumab